System, Monitoring, For Progress Of Labor

NPB · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 884.2800

Classification

FDA Product Code: NPB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.2800
Review panel: OB
Medical specialty: Ophthalmic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown